Critical and Advanced Intermediates
- We can assist you in selecting starting materials considering the current regulatory requirements while optimizing costs.
- We can plan with you a regulatory strategy to support your chosen starting material.
- Documentation for “critical” starting materials can be prepared in case these become GMP Intermediates.
By introducing a “backwards integration” solution package, we can help you in meeting stricter requirements for starting materials. Our services include:
- Supplier evaluation and qualification
- Compilation of regulatory documentation
- Regulatory support during registration and variation procedures.
We offer cost-effective solutions via N-1 intermediates produced under GMP for APIs under price pressure. Our services include those listed above under GMP Intermediates.
Midas enables access to chiral intermediates via either chemical or enzymatic catalysis.
Our proven track record rests upon broad experience and a range of narcotic intermediates for pharmaceutical applications. We comply with all regulations for narcotic and psychotropic substances, as well as precursors (scheduled substances "GüG"). We manage cross-border handling of controlled substances to meet your requirements.
Custom Synthesis Services — for non-sourceable and hard to find APIs/IMs, our experts can tailor a synthesis that satisfies any technological requirement. More
Intellectual Property Services — assure the successful course of proprietary development projects. They evaluate the intellectual property (IP) situation of Routes of Synthesis (RoS), clarify the legal status of EP patents (EPO), and do freedom to operate analysis (FTO) and associated reports. More
Quality Management Services — assess supplier and sites qualifications supporting all quality questions regarding GMP and N-1 intermediates. More
Regulatory Services — compile regulatory documentation required for GMP and N-1 Intermediates and provide crucial assistance during registration procedures. More
We support your project to prevent common pitfalls while enabling enduring success:
EDQM obtained 90 CEP applications in 2011. In the first attempt, 88 out of 90 failed due to deficiencies related to starting materials and key intermediate issues. More